IBD Clinical Trial
Official title:
Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD
Verified date | December 2022 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective, randomized, longitudinal, controlled project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to suspicion of IBD. Phase 2 (RCT) is only for patients who are diagnosed with IBD. These patients will be randomized to receive biofeedback intervention daily for 8 weeks or no biofeedback intervention. All participants will receive physician directed standard of care treatment.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 1, 2025 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | Inclusion Criteria: The inclusion criteria for Phase 1 are: 1. Age 8-17 years 2. Referred for a diagnostic colonoscopy with strong clinical concern for IBD 3. Live within a 2 hour drive of NCH There is one additional inclusion criterion for Phase 2: 1. Patients have been diagnosed with IBD Exclusion Criteria: 1. Participants are excluded if they have a comorbid chronic illness, perianal disease, current corticosteroid treatment, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment. 2. Age and language are limited by the demands of the study (questionnaire completion) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ross Maltz |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Crohn's disease mucosal healing | Simple endoscopic score for CD (SES-CD) scores ileum, right colon, transverse, left colon, and rectum for the degree of ulceration. Scale ranges from 0-3, total score is calculated from sum of all variables for all 5 locations. Scores range from 0-60. Higher scores indicate worse inflammation. | pre-diagnosis to 12 month follow up | |
Primary | Ulcerative Colitis Mucosal healing | Mayo endoscopic scores for the degree of ulceration. Scores range from 0-3. Higher scores indicate worse inflammation. | pre-diagnosis to 12 month follow up | |
Primary | Disease activity( Fecal calprotectin) | Fecal calprotectin levels from stool | pre diagnosis to 12 month follow up | |
Primary | Disease Activity (Crohn's disease) | Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-100. | pre diagnosis to 12 month follow up | |
Primary | Disease Activity ( Ulcerative Colitis) | Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-85. | pre diagnosis to 12 month follow up | |
Primary | Stress | PROMIS Pediatric Psychological Stress Experiences.Scores range from 0-60, with higher scores indicating higher levels of stress.Total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. | pre-diagnosis to 12 month follow up | |
Primary | Anxiety | PROMIS Pediatric Anxiety Short Form. Scores range from 0-60, with higher scores indicating higher levels of anxiety. Total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. | pre-diagnosis to 12 month follow up | |
Primary | Pediatric Quality of life | PedsQL. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. | pre-diagnosis to 12 month follow up | |
Primary | Depression | Children's Depression Inventory short form. Scores range from 0-54, with higher scores indicating higher levels of depression. Total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. | pre-diagnosis to 12 month follow up. | |
Secondary | Stress-related changes in the microbiome | Microbiome a and ß-diversity will be examined at pre-diagnosis, post-intervention, 4 month post-intervention, and 12 month follow-up to determine possible relationships between overall community structure between participants that received the intervention of biofeedback vs participants that were controls. | pre diagnosis to 12 month follow up | |
Secondary | Stress-related changes in the metabolome. | Random Forest (RF) and Boruta feature selection will be used from pre-diagnosis, post-intervention, 4 month post-intervention, and 12 month follow-up to identify metabolites and microbes.To further interpret the biological function of predictive metabolites, pathway enrichment analysis will be performed using the RaMP database, which integrates biological pathway and metabolite annotions from multiple sources (e.g. HMDB, KEGG, REACTOME, WikiPathways). | pre diagnosis to 12 month follow up |
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